Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) just revealed the Regulatory Body for Medicines & Healthcare Goods (MHRA) in the U.K. has given temporary permission for emergency use of their mRNA (BNT162b2) vaccine against COVID-19. This constitutes the first sanction for immediate use after a Phase 3 worldwide trial of a vaccine to combat the pandemic. Pfizer and BioNTech expect more regulatory decisions across the globe in the coming days and weeks and can supply vaccine doses following possible regulatory authorizations or approvals. The U.K. delivery priority would be set according to the groups identified in the Joint Committee on Vaccination and Immunisation guidelines (JCVI).
This year, Pfizer and BioNTech signed a partnership with the U.K. that once approved for emergency use, to provide 30 million doses of BNT162b2 mRNA-based vaccine. In early October, the deal was expanded to 40 million doses. The 40 million doses will be distributed in phases across 2020 and 2021 to ensure an equal distribution of vaccinations across geographies of contracts executed. Now that the vaccine is approved in the United Kingdom, businesses will take prompt steps to distribute the vaccine doses. It is predicted that the first doses will arrive in the U.K. With absolute distribution fulfillment expected in 2021, in the coming days.
The firms have applied with the U.S. for Emergency Use Permission. Following rolling applications to the European Medicines Agency (EMA) and many other regulatory bodies around the world, the Food and Drug Administration (FDA) has applied the final Conditional Marketing Authorization Application (CA).